Andaman Medical is a regulatory affairs and market access consultancy specializing in the registration, authorized representation, importation and master distribution of medical device and in-vitro diagnostics in Southeast Asia.
Our in-house team of local, experienced regulatory affairs specialists provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise.
Acting as the in-country representative, we prepare, submit and manage device registrations for our clients giving them independence and flexibility over their market access and distribution strategy. And we provide them with the ongoing insight on how to navigate the complex regulatory arena, increasing post-market surveillance (PMS) and constantly updated compliance requirements.
Leveraging our local expertise and presence, our clients can access markets with even greater ease thanks to our importation and master distribution services. We ensure medical devices obtain customs clearance and are distributed to the end customer, leaving clients to concentrate on their business.
Founded in 2013, we decided to focus exclusively on Southeast Asia and have grown over the last seven years to open seven offices in Singapore, Malaysia, Indonesia, Philippines, Vietnam, and Thailand, registering, maintaining, and importing 1000+ medical devices of all classes and all therapeutic areas from ophthalmics to orthopedics, from cardiovascular to CNS, from diabetes to diagnostics and much, much more. For more information about Andaman Medical, visit www.andamanmed.com.
22 June 2021
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